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A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus

Phase 2
Not Enrolling
Discoid Lupus Erythematosus

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Trial Information

A Pilot Trial of Topical Thalidomide for the Management of Chronic Discoid Lupus Erythematosus

The purpose of this double-masked, pilot trial is to determine whether 20 % thalidomide
ointment is safe and effective for the treatment of chronic discoid lupus erythematosus
(CDLE) when used under an occlusive dressing. Seventeen patients with two similar lesions
will have lesions randomized to receive either intervention or placebo therapy.

Inclusion Criteria

Age, 18 or more.

Must have lesions that fulfill clinical and histologic criteria for active CDLE.

Lesions must be of at least 3 months duration and must not have been treated with topical
steroids or retinoids for at least 3 weeks.

Patient must have at least two similar lesions that can accommodate a 2X3 inch dressing.

Patient must be willing to have two 4 mm biopsies prior to onset of therapy and four 4 mm
biopsies at the end of the study period.

In the absence of systemic involvement, the CDLE lesions must not have responded to at
least 3 months of therapy with topical steroids, sunscreens with or without antimalarials
such as hydroxychloroquine.

If CDLE is present in association with systemic involvement, the lesions must not have
responded to 3 months of stable conventional systemic therapy and/or topical steroids and

If female, the patient must have a negative pregnancy test prior to study entry.

If female, must be postmenopausal surgically sterile, sexually inactive, or practicing
successful contraception with two methods of birth control simultaneously for at least one
month prior to starting on thalidomide and continue use for another month after the last
application of thalidomide.

If male, the patient must be surgically sterilized, sexually inactive, or use a condom
during the study and continue regular use until one month after the last application of

Patients must have normal cognitive abilities to be able to understand the experimental
nature of the therapy, to be able to follow instructions regarding application of
medication and correct use of contraceptive measures.

Patients must not be pregnant or lactating.

Patients must not have renal disease (serum creatinine greater than 2 times the upper
limit of normal.

Patients must not have hepatic dysfunction (liver function tests greater than 2 times the
upper limit of normal).

Patients must not have unstable systemic lupus erythematosus such that systemic therapy
cannot be maintained at steady doses for the duration of the study.

Patients must not use topical steroids for the duration of the study.

Patients must not be currently receiving systemic thalidomide.

Patients must not be hypersensitive to thalidomide.

Patients must not have presence of polyneuropathy (objective sensory loss or motor
weakness or reflex loss) with the exception of focal nerve entrapment syndromes (such as
carpal tunnel syndrome), or receiving drugs with known or suspected neuropathic side

Patients must not have any other condition or therapy which in the opinion of the
investigators may pose a risk to the patient or confound the results of the study.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

October 1997

Completion Date:

July 2001

Related Keywords:

  • Discoid Lupus Erythematosus
  • Double-masked
  • Neuropathy
  • Occlusive Dressing
  • Pilot
  • Placebo
  • Lupus Erythematosus, Discoid
  • Lupus Erythematosus, Systemic



National Cancer Institute (NCI) Bethesda, Maryland  20892